West Nile Fever Encephalitis Clinical Trial
Official title:
Phase 1 Study of the Safety and Immunogenicity of West Nile/Dengue-4 3'delta30 Chimeric Virus Vaccine (WN/DEN4-3'delta30), a Live Attenuated Vaccine for West Nile Encephalitis
West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis, coma, and death. The purpose of this study is to test the safety of and immune response to a WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed against dengue virus.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Willing to be followed for the duration of the study - Willing to use acceptable methods of contraception - Good general health Exclusion Criteria: - Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease - Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study - Hematologic disease - History of migraine headaches - History of encephalitis - Alcohol or drug abuse within 12 months prior to study entry - History of severe allergic reaction or anaphylaxis - Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry - HIV-1 infected - Hepatitis C virus infected - Hepatitis B surface antigen positive - Known immunodeficiency syndrome - Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded. - Live vaccine within 4 weeks prior to study entry - Killed vaccine within 2 weeks prior to study entry - Blood products within 6 months prior to study entry - Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while participating in this study - Previously received a licensed or experimental yellow fever, tick-borne encephalitis, or dengue vaccine - Surgical removal of spleen - History of West Nile encephalitis - History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus) - Other condition that, in the opinion of the investigator, would affect the participant's participation in the study - Pregnancy or breastfeeding |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins School of Public Health | Baltimore | Maryland |
| United States | Vanderbilt University School of Medicine | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Johns Hopkins Bloomberg School of Public Health |
United States,
Chang GJ, Kuno G, Purdy DE, Davis BS. Recent advancement in flavivirus vaccine development. Expert Rev Vaccines. 2004 Apr;3(2):199-220. Review. — View Citation
Lai CJ, Monath TP. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res. 2003;61:469-509. Review. — View Citation
Monath TP, McCarthy K, Bedford P, Johnson CT, Nichols R, Yoksan S, Marchesani R, Knauber M, Wells KH, Arroyo J, Guirakhoo F. Clinical proof of principle for ChimeriVax: recombinant live, attenuated vaccines against flavivirus infections. Vaccine. 2002 Jan 15;20(7-8):1004-18. — View Citation
Pletnev AG, Claire MS, Elkins R, Speicher J, Murphy BR, Chanock RM. Molecularly engineered live-attenuated chimeric West Nile/dengue virus vaccines protect rhesus monkeys from West Nile virus. Virology. 2003 Sep 15;314(1):190-5. — View Citation
Pugachev KV, Guirakhoo F, Trent DW, Monath TP. Traditional and novel approaches to flavivirus vaccines. Int J Parasitol. 2003 May;33(5-6):567-82. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of vaccine-related adverse effects, graded by severity, for each dose | Throughout study | Yes | |
| Primary | Immunogenicity of vaccine against WN virus | Throughout study | No | |
| Secondary | To assess the durability of the antibody response | At Day 180 | No | |
| Secondary | To assess the frequency, quantity, and duration of viremia in each dose cohort studied | Throughout study | No | |
| Secondary | To assess the immunogenicity of the WN/DEN4-3'delta30 vaccine against WN wild-type virus | Throughout study | No | |
| Secondary | To compare the T cell medicated immune response against West Nile virus of those volunteers infected with the WN/DEN4-3'delta30 vaccine virus with that of uninfected volunteers and placebo recipients | At study completion | No | |
| Secondary | To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy | Throughout study | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04371003 -
Prospective Investigation of Oxidative Stress in West Nile Virus Infection
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